JAMA Study Continues Wave Of Accelerated Approval Criticism Amid Expansion Of Pathway

Sponsors are increasingly using the accelerated approval pathway, but research continues to be critical about its aspects.

Box fighters trainning outdoor . Mixed media

Drugmakers have increasingly been pursuing the accelerated approval route after 2010, but the regulatory pathway has nonetheless been subject to a fresh wave of criticism from researchers, with the Journal of the American Medical Association (JAMA) most recently raising concerns.

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Device-Like System Proposed For Low-Risk Human Cell Therapies, Tissue-Based Products At US FDA

 
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A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system.

US FDA Under Makary: MAHA With A Lighter Touch

 

US FDA Commissioner nominee Martin Makary is being embraced by industry, and Senate Democrats, as a more traditional pick than other Trump Administration nominees, but the Make America Healthy Again agenda still is clearly coming to the agency.

New EU Approvals

 

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Vimkunya, Bavarian Nordic's chikungunya vaccine.

Unfreezing US FDA: Generic Drug Officials Make Plea For Public Workshops

 

The FDA generic drugs team’s first public workshop of the second Trump Administration ended with a request that industry amplify the value it finds from public engagement.

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EMA Considers Whether Intrathecal Zolgensma Deserves Fast Tracking

 

Novartis is planning to file EU and US marketing applications for an intrathecal formulation of its spinal muscular atrophy gene therapy, Zolgensma, in H1 2025.

Surrogate Endpoint ‘Reasonably Likely’ Decision Process An ‘Uncertain Standard,’ Industry Says

 
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The FDA’s accelerated approval draft guidance has left stakeholders seeking clarification of the process for determining a surrogate marker or intermediate clinical endpoint is reasonably likely to confirm clinical benefit.

Device-Like System Proposed For Low-Risk Human Cell Therapies, Tissue-Based Products At US FDA

 
• By 

A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system.